UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Acronym	Lung cancer chemothrapy, diarrhea, and Clostridium difficile-colitis study
Scientific Title	Investigation of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Scientific Title:Acronym	Lung cancer chemothrapy, diarrhea, and Clostridium difficile-colitis study
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Basic objectives2	Others
Basic objectives -Others	To estimate the incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of diarrhea and Clostridium difficile-colitis after lung cancer chemotherapy
Key secondary outcomes	a preventive effect of probiotics against Clostridium difficile-colitis after lung cancer chemotherapy an effect of treatment for Clostridium difficile-colitis after lung cancer chemotherapy

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	an age of at least 20 years histologically or cytologically confirmed lung cancer scheduled for chemotherapy of TS-1, CPT-11, or taxane-anticancer drugs an Eastern Corporative Oncology Group (ECOG) performance status of 3 or less without diarrhea a life expectancy of at least 3 months
Key exclusion criteria	ileus diarrhea for more than three times a day before the administration of the anticancer agent a history of Clostridium difficile infection in the 2 months before enrollment mental disorders require the administration of antipsychotic major complications interfere with the continuation of the treatment
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Shunichi Middle name Last name Sugawara
Organization	Sendai Kousei Hospital
Division name	respiratory medicine
Zip code	980-0873
Address	4-15,Hirosemachi,Aoba-ku,Sendai,Miyagai, Japan
TEL	81-22-222-6181
Email	swara357@cat-v.ne.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Kobayashi
Organization	North Japan Lung Cancer Study Group
Division name	Sendai Kousei Hospital
Zip code	980-0873
Address	4-15,Hirosemachi,Aoba-ku,Sendai,Miyagai, Japan
TEL	81-22-222-6181
Homepage URL
Email	ktakao@cat-v.ne.jp

Sponsor
Institute	North Japan Lung Cancer Study Group
Institute
Department

Funding Source
Organization	North Japan Lung Cancer Study Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sendai Kousei hospital
Address	4-15, Hirosemachi, Aoba-Ku, Sendai, Miyagi,Japan
Tel	81-22-222-6181
Email	yuktoi119@yahoo.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 29 Day

Related information
URL releasing protocol	https://doi.org/10.3389/fonc.2021.685320
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.3389/fonc.2021.685320
Number of participants that the trial has enrolled	263
Results	Grade 2 or higher diarrhea was observed in 22 patients(8.4%); Clostridium difficile infection(CDI) was confirmed in five of them. The incidence of CDI was 22.7% of all diarrhea cases.
Results date posted	2021 Year 12 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	lung cancer chemotherapy patients
Participant flow	Participants were enrolled by each institutes.
Adverse events	not observed
Outcome measures	Grade 2 or higher diarrhea was observed in 22 patients(8.4%); Clostridium difficile infection(CDI) was confirmed in five of them. The incidence of CDI was 22.7% of all diarrhea cases.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Date of IRB	2012 Year 09 Month 10 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	record the case of diarrhea after lung cancer chemotherapy

Management information
Registered date	2012 Year 07 Month 13 Day
Last modified on	2021 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009921